The following data is part of a premarket notification filed by Endo Optiks, Inc. with the FDA for Microprobe Laser And Endoscopy System, Model E2.
| Device ID | K042918 |
| 510k Number | K042918 |
| Device Name: | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Contact | Keith Hertz |
| Correspondent | Keith Hertz ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-22 |
| Decision Date | 2004-11-22 |
| Summary: | summary |